Prospecto: Information for the user

Levetiracetam Aurovitas 100 mg/ml concentrate for infusion solution EFG

Read this prospect carefully before you or your child start using this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Levetiracetam Aurovitas and what is it used for

2.What you need to know before starting to use Levetiracetam Aurovitas

3.How to use Levetiracetam Aurovitas

4.Possible adverse effects

5.Storage of Levetiracetam Aurovitas

6.Contents of the pack and additional information

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Levetiracetam is used:

•alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy, to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which the seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.

•concurrently with other antiepileptic medications to treat:

-partial onset seizures with or without generalization in adults, adolescents, and children 4 years of age or older.

-myoclonic seizures (shock-like, short, muscle or group of muscles) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.

-primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Levetiracetam concentrate is an alternative for patients in whom oral administration is not viable temporarily.

No useLevetiracetamAurovitas

•If he is allergic to levetiracetam, pyrrolidone derivatives, or any of the other components ofthis medication (listed in section 6).

Warnings and precautions

Consult a doctor before starting to useLevetiracetam Aurovitas.

•If he has kidney problems, follow the doctor's instructions, who will decide if the dose needs to be adjusted.

•If he observes any delay in his child's growth or an unexpected onset of puberty, contact his doctor.

•A small number of people taking antiepileptic medications like levetiracetam have had thoughts of self-harm or suicide. If he has any symptoms of depression and/or suicidal thoughts, contact his doctor.

•If he has a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if he has a disease and/or is taking a treatment that makes him prone to arrhythmias or electrolyte imbalances.

Inform his doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

•Abnormal thoughts, feeling of irritability, or reacts more aggressively than normal, or if he or his family and friends notice significant changes in mood or behavior.

•Worsening of epilepsy

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (epilepsy associated with SCN8A mutations) that causes multiple types of seizures and loss of skills, he may notice that seizures persist or worsen during treatment.

If he experiences any of these new symptoms while using levetiracetam, he should visit a doctor as soon as possible.

Children and adolescents

Monotherapy with levetiracetam (exclusive treatment) is not indicated in children and adolescents under 16 years old.

Other medications andLevetiracetamAurovitas

Inform his doctor or pharmacist if he is using, has used recently, or may need to use any other medication, including over-the-counter medications.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If he is pregnant or breastfeeding, or thinks he may be pregnant, or intends to become pregnant, consult his doctor or pharmacist before using this medication. Levetiracetam can only be used during pregnancy if, after careful evaluation, his doctor considers it necessary. Do not stop treatment without discussing it with his doctor first.

The risk of birth defects for the baby cannot be completely ruled out.

It is not recommended to breastfeed naturally during treatment.

Driving and operating machinery

Levetiracetam may affect his ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. He should not drive or operate machinery until it is confirmed that his ability to perform these activities is not impaired.

LevetiracetamAurovitas contains sodium

Dose of 250 mg and 500 mg:

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

Dose of 1,000 mg:

This medication contains 38 mg of sodium (main component of table salt/for cooking) in each 2 vials. This is equivalent to 1.9% of the maximum daily sodium intake recommended for an adult.

Dose of 1,500 mg:

This medication contains 57 mg of sodium (main component of table salt/for cooking) in each 3 vials. This is equivalent to 2.85% of the maximum daily sodium intake recommended for an adult.

A doctor or nurse will administer levetiracetam through intravenous infusion.

Levetiracetam should be administered twice a day, once in the morning and once at night, approximately at the same time each day.

The intravenous formulation is an alternative to oral administration. You can switch from coated tablets or oral solution to the intravenous formulation, or vice versa, directly without adjusting the dose. Your total daily dose and administration frequency must be identical.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (12 to 17 years) with a weight of 50 kg or more:

Recommended dose: between 1,000 mg and 3,000 mg per day.

When starting to use levetiracetam, your doctor will prescribe a lower dose for two weeks before administering the lowest daily dose.

Dose in children (4 to 11 years) and adolescents (12 to 17 years) with a weight less than 50 kg:

Recommended dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.

Form and route of administration:

Levetiracetam Aurovitas for intravenous administration.

The recommended dose should be diluted in at least 100 ml of a compatible diluent and administered by intravenous infusion over 15 minutes.

For doctors and nurses, more detailed information for the correct use of Levetiracetam Aurovitas is provided in section 6.

Duration of treatment:

• No experience is available with the administration of intravenous levetiracetam for a period exceeding 4 days.

If treatment with Levetiracetam Aurovitas is interrupted

Like with other antiepileptic medications, the discontinuation of levetiracetam treatment should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with levetiracetam, they will give you instructions for the gradual withdrawal of levetiracetam.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency department of your nearest hospital if you experience:

•weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis).

•swelling of the face, lips, tongue, or throat (Quincke's edema).

•flu-like symptoms and a rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia), and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS)).

•symptoms such as decreased urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline.

•a skin rash that can form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme).

•a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

•a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).

•signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory deterioration (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (drowsiness), headache, fatigue, and dizziness. Side effects such as drowsiness, weakness, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

•nasopharyngitis.

•drowsiness (drowsiness), headache.

Common: may affect up to 1 in 10 people

•anorexia (loss of appetite).

•depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability.

•seizures, balance disorder, dizziness (sensation of instability), lethargy (lack of energy and enthusiasm), tremor (involuntary tremor).

•vertigo (sensation of rotation).

•cough.

•abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea.

•skin rash.

•asthenia/fatigue (sensation of weakness).

Uncommon: may affect up to 1 in 100 people

•decreased platelet count, decreased white blood cell count.

•weight loss, weight gain.

•suicidal thoughts and attempts, mental alterations, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation.

•amnesia (memory loss), memory deterioration (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration).

•diplopia (double vision), blurred vision.

•elevated/abnormal liver function test results.

•hair loss, eczema, itching.

•muscle weakness, myalgia (muscle pain).

•injury.

Rare: may affect up to 1 in 1,000 people

•infection.

•decreased count of all types of blood cells.

•severe allergic reactions (DRESS, anaphylactic reaction (severe allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat)).

•decreased sodium concentration in blood.

•suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating).

•delirium.

•encephalopathy (see subsection “Inform your doctor immediately” for a detailed description of symptoms).

•seizures may worsen or occur more frequently.

•involuntary muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity).

•change in heart rhythm (electrocardiogram).

•pancreatitis (inflammation of the pancreas).

•liver insufficiency, hepatitis (inflammation of the liver).

•sudden decline in kidney function.

•skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis).

•myolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

•gait disturbance or difficulty walking.

•combination of fever, muscle rigidity, unstable blood pressure and heart rate, confusion, and low level of consciousness (may be signs of a condition called neuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• repeated or unwanted thoughts or sensations and the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the vial and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Stability has been demonstrated physically and chemically in use for 24 hours at 2-8°C and at 15-25°C.

From a microbiological point of view, unless the opening method prevents the risk of microbiological contamination, the product should be used immediately. If not used immediately, storage times and conditions in use are the responsibility of the user.

Do not use Levetiracetam Aurovitas if you observe particles or signs of discoloration.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This way, you will help protect the environment.

Composition ofLevetiracetam Aurovitas

-The active ingredient islevetiracetam. Each ml of infusion solution contains 100 mg of levetiracetam.

-The other components are: sodium chloride, sodium acetate trihydrate and water for injection preparations.

Aspect of the product and content of the package

Levetiracetam Aurovitas concentrated solution for infusion is a transparent and colorless solution.

The vial of Levetiracetam Aurovitas concentrated solution for infusionis packaged in a cardboard box with 1 and 10 vials.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Eugia Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana, FRN 1914

Malta

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: November 2023

This information is intended solely for healthcare professionals:

The instructions for the proper use of this medication are provided in section 3.

A vial oflevetiracetamconcentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate). See Table 1 for the recommended preparation and administration of levetiracetam concentrated solution for infusion to achieve a total daily dose of 500 mg, 1,000 mg, 2,000 mg or 3,000 mg divided into two doses.

Table 1. Preparation and administration of levetiracetam concentrate

This medication is for single use only, so the unused solution must be discarded.

This medication is physically compatible and chemically stable when mixed with the following diluents for at least 24 hours at controlled room temperature (15-25°C) within the concentration range of 2.5 mg/ml to 13 mg/ml.

Diluents:

•Sodium chloride injection 9 mg/ml (0.9%)

•Ringer lactate injection

•Glucose injection 50 mg/ml (5%)